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JAMA Publishes Previously Blocked Covid-19 Vaccine Study

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JAMA publishes a controversial Covid-19 vaccine effectiveness study, which was previously blocked from publication in a Centers fo...

FDA FY 2027 Appropriation Report Analyzed

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Eight Hyman, Phelps & McNamara attorneys analyze a House Appropriations Committee report that explains its rationale and expectati...

FTC Weighs in Against J&J in Stelara Monopoly Case

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The Federal Trade Commission files an amicus brief supporting plaintiffs in an antitrust lawsuit accusing Johnson & Johnson of unl...

FDA Details Standardized Approach to Drug Safety Signal Detection

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A new CDER Office of New Drugs webinar discusses the development and use of OND Custom Medical Queries to identify potential safet...

Require IDE for Venas MicroAngioscope: Petition

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Harmed Americans for Reform in Medical Device Safety petitions FDA to require an IDE for the Vena MicroAngioscope and take other s...

4 CGMP Violations in Huons Inspection

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FDA warns South Koreas Huons Co. about CGMP violations in its manufacturing of finished drugs.

FDA Leadership Upheaval Yields Uncertainty: Post

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A Skadden Insights post raises the concern of FDA-regulated companies caused by the significant leadership changes at the agency.

FDA Issues Early Alert on Abiomed Impella Introducer Kits

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FDA issues an early alert warning healthcare providers about a potentially high-risk device issue involving introducer kits used w...

FDA Bought Unapproved New Drugs on Amazon

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FDA warns Amazon it is marketing unapproved new drugs on its Web site.

Gottlieb Praises Clinical Trial Initiative; Calls for FDA Career Leadership

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Former FDA commissioner Scott Gottlieb supports the agency's newly announced initiative to accelerate early-stage clinical trials...